# Ziftomenib

Source: https://onco.cc/drugs/ziftomenib/  
OnCo record `ziftomenib` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Ziftomenib is the second menin inhibitor for leukaemia, approved in November 2025 as a once-daily pill for relapsed NPM1-mutated AML.

## Summary

KOMET-001 (n=112 relapsed/refractory NPM1-mutated AML): CR 23%, ORR 33%, median OS 6.6 months. Approved 13 November 2025 (Kura Oncology / Kyowa Kirin). KOMET-007 combines ziftomenib with 7+3 and with venetoclax-azacitidine in newly diagnosed NPM1-mutated and KMT2A-rearranged AML, with high remission rates in early cohorts; KOMET-017 phase 3 registration studies are underway. Menin inhibition also being tested in KMT2Ar ALL.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Komzifti
- Modality: Small-molecule menin inhibitor
- Mechanism: Displaces KMT2A/KMT2A-fusion complexes from menin, silencing HOXA9/MEIS1 and releasing the differentiation block in NPM1-mutant and KMT2A-rearranged blasts.
- Approvals: US 2025: Relapsed/refractory NPM1-mutated AML with no satisfactory alternative
- Dosing: Oral; 600 mg once daily until progression

## Sources

- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Ziftomenib

## Connected records

- drugs: [Revumenib](https://onco.cc/drugs/revumenib/)
- biomarkers: [NPM1 mutation](https://onco.cc/biomarkers/npm1-mutation/)
- cancers: [Acute lymphoblastic leukaemia](https://onco.cc/cancers/all-leukemia/), [Acute myeloid leukaemia](https://onco.cc/cancers/aml/), [Acute myeloid leukaemia in children](https://onco.cc/cancers/aml-paediatric/), [Infant acute lymphoblastic leukaemia (KMT2A-rearranged, under one year)](https://onco.cc/cancers/all-infant/), [NPM1-mutated and KMT2A-rearranged acute myeloid leukaemia](https://onco.cc/cancers/aml-npm1-kmt2a/)
- technologies: [Epigenetic drugs (HDAC, DNMT, EZH2, IDH, menin, BET)](https://onco.cc/technologies/epigenetic-drugs/), [Menin inhibitors](https://onco.cc/technologies/menin-inhibitors/)
- targets: [HOXA9](https://onco.cc/targets/hoxa9/), [KMT2A (MLL) rearrangement](https://onco.cc/targets/kmt2a/), [MEIS1](https://onco.cc/targets/meis1/), [Menin](https://onco.cc/targets/menin/), [NPM1 mutation](https://onco.cc/targets/npm1/)
- companies: [Kura Oncology](https://onco.cc/companies/kura-oncology/)
- terms: [Differentiation syndrome](https://onco.cc/terms/differentiation-syndrome/)
- trials: [A Phase 2 Clinical Study of Ziftomenib in Patients With Relapsed or Refractory NPM1-Mutated Acute Myeloid Leukemia](https://onco.cc/trials/nct07623616/), [KOMET-001](https://onco.cc/trials/komet-001/), [myeloMATCH](https://onco.cc/trials/myelomatch/), [Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML](https://onco.cc/trials/nct07007312/)
- pairings: [Menin inhibitor + venetoclax + azacitidine](https://onco.cc/pairings/menin-plus-venetoclax-hma/)
- ideas: [Menin inhibitors for infant KMT2A-rearranged ALL](https://onco.cc/ideas/idea-menin-infant-all/)
- pathways: [Epigenetic reprogramming](https://onco.cc/pathways/epigenetic-reprogramming/), [Menin / KMT2A (HOXA9-MEIS1 axis)](https://onco.cc/pathways/menin-kmt2a/), [Transcriptional machinery & addiction](https://onco.cc/pathways/transcription-addiction/)
- bottlenecks: [The undruggable drivers](https://onco.cc/bottlenecks/b-undruggable-targets/)
- key papers: [AUGMENT-101: revumenib, the first menin inhibitor, in relapsed leukaemias driven by KMT2A rearrangement or NPM1 mutation](https://onco.cc/key-papers/paper-augment-101-revumenib-menin-nature-2023/)
- roadmaps: [Epigenetic therapy roadmap: loosening silenced genes → mutation-specific enzymes → editing the epigenome](https://onco.cc/roadmaps/epigenetics-roadmap/)

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